To evaluate the safety and efficacy of Phenazopyridine HCl Tablets, USP 200 mg as a short term analgesic treatment of pain or burning when passing urine associated with uUTI.
- Conditions
- Health Condition 1: null- Uncomplicated Urinary Tract Infection
- Registration Number
- CTRI/2010/091/000552
- Lead Sponsor
- Amneal Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria:
1. Females, 18 years of age or older
2. Able to give written informed consent
3 Diagnosis of uncomplicated urinary tract infection
4. Must have one of the following uUTI diagnosis - Cystitis or Urethritis
5. A positive urine dipstick showing nitrate or leukocyte esterase (LE)
6. Negative Urine Pregnancy Test (if applicable)
7. Must have one or both of the following symptom of - pain upon urination, burning upon urination
8. In addition, any one of the following symptoms that subject reports
a) Not being able to empty bladder completely
b) Pain or discomfort in lower abdomen, or pelvic areas caused by UTI
c) Frequent urge to urinate
d) Blood in urine
e) Low back pain caused by your urinary tract infection
Exclusion Criteria:
1. Any diagnosis of a urinary tract or kidney disorder that is not a uUTI
2. A diagnosis of Pyelonephritis (kidney infections when lower uUTI spreads to the upper tract)
3. Women with a history of prior use of phenazopyridine hydrochloride
4. Women who have taken any systemic anti-infectives within seven days of study participation.
5. Women with a history of G-6-PD deficiency or hemolytic anemia
6. Women who have a known history of anatomical genitourinary (GU) anomalies or GU surgery within the past 6 months
7. Women of child bearing age who do not consent to a pregnancy test
8. Women who are lactating
9. Chronic infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound or cystoscopy
10. Subjects with clinically significant abnormal results or finding on the screening physcal examination, laboratory tests, vital signs or ECG
11. Subjects unabele to comprehend the language of the informed consent and the self evaluation scales
12. Subject with serious acute illness (e.g. pneumonia) or an untreated or unstable medical illness that would likely interfere with assessments of uUTI
13. Subjects who have received an investigational medication as a part of a drug trial 3 months prior to the baseline study visit
14. Subjects with a history of severe drug allergy or hypersensitivity
15. Subjects with a known sensitivity to Phenazopyridine, Hyoscyamine, Butabarbital and antibiotics
16. Employees of the investigator or institution who have direct involvement in the trial or other trials under the direction of the investigator or their associates
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Efficacy will be based on Subject's self evaluation of the symptom of pain or burning when passing urineTimepoint: Relief of pain or burning when passing urine will be compared from baseline to 24 hours and 48 hours of treatment
- Secondary Outcome Measures
Name Time Method Evaluation and Assessment of uncomplicated Urinary Tract Infection will be based on the subject's evaluation on one or more of the following: <br>1. Frequency of urination<br>2. Urgency of urination<br>3. Not being able to empty bladder completely/ passing only small amount of urine<br>4. Pain or uncomfortable pressure in lower abdomen or pelvic area caused by UTI<br>5. Low back pain caused by UTI<br>6. Blood in Urine<br><br>In addition overall rating will be assessed by the subjectsTimepoint: At <br>Baseline visit<br>24 hours<br>48 hours